MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-05-10 for MOSS MARK IV NASAL TUBE 6-87168 manufactured by Moss Tubes, Inc..
[2724694]
Ms. (b)(6) submitted a report and a copy was sent to moss tubes, inc. She states that pt complained of discomfort when moss-nasal tube was removed. The balloon was deflated before removal and a topical gel was prescribed. "no permanent injury". We have no record of this hospital purchasing any moss nasal tubes (b)(4) from us. Should this be one of our tubes obtained from another source, the description of event does not indicate any malfunction or defect of tube. Ms. (b)(6), also, states that device was discarded so there is no way for moss tubes to establish whether the tube in question was one of ours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320599-2007-00001 |
| MDR Report Key | 2624721 |
| Report Source | 99 |
| Date Received | 2007-05-10 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-03-26 |
| Date Added to Maude | 2012-06-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOSS MARK IV NASAL TUBE |
| Generic Name | MOSS NASAL TUBE |
| Product Code | BSS |
| Date Received | 2007-05-10 |
| Model Number | 6-87168 |
| Catalog Number | 6-87168 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOSS TUBES, INC. |
| Manufacturer Address | 749 COLUMBIA TURNPIKE EAST GREENBUSH NY 12061 US 12061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-10 |